ISO 13485 scope ISO 17665

ISO 17665 is an international standard concerning the sterilization of medical devices using heat and steam. It specifies requirements and guidelines for sterilization through autoclaving, a process using heat and water vapor to eliminate microorganisms from medical instruments and associated equipment.

This standard outlines sterilization parameters such as temperature, pressure, duration, and other essential conditions to ensure proper sterilization of medical devices. It also provides guidance on validation and qualification of sterilization cycles, along with quality control procedures to ensure devices are sterile and safe for use.